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Mechanical ventilation causes rapid diaphragm muscle atrophy, detectable within 18 hours of ventilator support, which is a major contributor to weaning failure and prolonged ICU stay.
This randomized controlled trial tests whether a physiotherapist-guided inspiratory endurance training program - achieved by progressively reducing pressure support (PS) levels on the ventilator - can preserve or improve inspiratory muscle strength and diaphragm structure in critically ill adults on mechanical ventilation, compared to standard ICU care.
Participants will be randomly assigned to one of two groups. The intervention group will receive twice-daily training sessions (weekdays only) in which the physiotherapist gradually reduces PS by up to 50% of the baseline level, causing the patient to breathe with greater muscular effort - equivalent to progressive endurance exercise for the diaphragm. The control group will receive standard weaning care as directed by the attending intensivist.
The primary outcome is maximal inspiratory pressure (PImax) at day 7. Secondary outcomes include diaphragm thickening fraction measured by ultrasound, time to successful extubation, weaning success rate, and mortality.
All measurements are performed by the ICU physician (blinded to group allocation) using airway occlusion maneuvers recorded on the ventilator and diaphragm ultrasound, following a standardized protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inspiratory Resistance Training (IRT-PS) | Experimental | Physiotherapist-guided inspiratory endurance training by progressive pressure support reduction (25-50% of baseline PS), 1-3 sets of 5-15 minutes, twice daily on weekdays, for up to 14 days or until extubation. Target: Borg CR10 score 3-5. P0.1 monitored continuously; sessions stopped if P0.1 > 4 cmH2O sustained > 2 minutes. |
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| Standard Care (Usual Care) | Active Comparator | Conventional weaning as directed by the attending intensivist, without a structured inspiratory muscle training program. Conventional physiotherapy (early mobilization, chest physiotherapy) is permitted in both groups. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progressive Pressure Support Reduction (IRT-PS) | Behavioral | Progressive reduction of pressure support (PS) during ventilator-assisted breathing, performed by a physiotherapist twice daily (weekdays only). Sessions consist of 1-3 sets of 5-15 minutes with 2-minute rest intervals at baseline PS. PS is reduced by 25% initially up to a maximum of 50% of baseline (minimum 5 cmH2O) for PS ≥10 cmH2O; by 1-2 cmH2O for PS 5-9 cmH2O; and by 1 cmH2O down to 0 cmH2O for PS <5 cmH2O. Target perceived exertion: Borg CR10 3-5. P0.1 monitored continuously; session stopped if P0.1 >4 cmH2O sustained >2 minutes (Goligher et al. criteria). Safety stop criteria: RR >35 rpm, SpO2 <90%, HR >120 bpm. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Inspiratory Pressure (PImax) | Measured by manual airway occlusion at end-expiration with pressure curve recorded on the ventilator. Standardized verbal instruction given to the patient. Best of 3 valid maneuvers recorded. Performed by the ICU physician blinded to group allocation. | Day 7 from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Diaphragm Thickening Fraction (DTF) | measured by ultrasound (linear probe 7-15 MHz, zone of apposition, M-mode, average of 3 cycles). Performed by ICU physician per standardized protocol. | Days 0, 3, 7 and 14 from randomization |
| P0.1 (Airway Occlusion Pressure at 100ms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ricardo Miguel Rodrigues-Gomes | Contact | +34618060702 | ric.mr.gomes@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Álvaro Cunqueiro | Vigo | Spain |
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| Standard ICU Care | Other | Conventional weaning managed by the attending intensivist according to standard clinical practice, without a structured inspiratory muscle training protocol. Conventional physiotherapy (early mobilization, chest physiotherapy) permitted in both groups. |
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respiratory drive indicator, read directly from ventilator display |
| Baseline and days 3, 7 and 14; and at start, mid and end of each training session (intervention group) |
| Time to Successful Extubation | hours from randomization to extubation without reintubation within 48 hours | From randomization until extubation, up to 14 days |
| Weaning Success Rate | proportion of patients extubated without reintubation within 48 hours | Days 7 and 14 from randomization |
| Sustained Pressure Support Reduction | difference in cmH2O between baseline PS at Day 0 and Day 7 | days 1, 3, 5 and 7 from randomization |
| Total Days on Mechanical Ventilation | From randomization until ICU discharge, up to 30 days |
| ICU Mortality | At the time of ICU discharge (up to 24 weeks) |
| 30-day Mortality | Day 30 from randomization |
| ICU Readmission at 30 days | Day 30 from randomization |
| Borg CR10 Score during training session | perceived respiratory exertion (0-10) | Periprocedural (from the start of the session until 30 minutes post-intervention) |
| Adverse events during training sessions | episodes of RR >35, SpO2 <90%, HR >120 bpm | Periprocedural (from the start of the session until 30 minutes post-intervention) |